510(k) K934880
- Device
- MTI PHOTOSCREENER
- Applicant
- MEDICAL TECHNOLOGY AND INNOVATIONS, INC.
- 510(k) number
- K934880
- Product code
- MMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-04-06
- Date received
- 1993-10-12
- Regulation
- 886.1120
- Classification name
- Photorefractor
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEREMY P FEAKINS
- Address
- 1710 Adams St. Cedar Falls IA US 50613 50613
FDA Registration Numbers#
- 2320749
- 3010539401
- 3012162565
- 3013436538
Source Documents#
Legacy Summary#
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FDA Review#
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